• Nuance Pharma announces approval of Ohtuvayre ensifentrine inhalation suspension for the treatment of COPD in Hong Kong

  Nuance Pharma announced that the Hong Kong Drug Office has approved Ohtuvayre ensifentrine inhalation suspension for the treatment of COPD. According to Nuance, Ohtuvarye had been available through certain medical facilities in Macau and Hong Kong… [Read more . . .]

• Orbia announces submission of DMF for Zephex 152a LGWP MDI propellant

  Orbia Fluor & Energy Materials (previously Koura, Mexichem) has announced the submission of a drug master file for its HFA 152a MDI propellant, marketed as Zephex 152a. The company kicked off the transition to low global warming potential… [Read more . . .]

• Bespak to increase MDI capacity at its Holmes Chapel site to support Chiesi LGWP transition

  Chiesi and Inhalation CDMO Bespak have announced an expansion of an existing partnership to increase manufacturing capacity for LGWP propellant MDIs at Bespak’s Holmes Chapel, UK site. Chiesi announced plans to launch an HFA 152a inhaler by… [Read more . . .]

• Kenox now offering clinical manufacturing for OINDPs

  US-based CDMO Kenox Pharmaceuticals announced that it is now able to offer clinical manufacturing for OINDPs and has expanded its testing services for OINDPs, including in vitro BE.  In January 2025, the company said that it… [Read more . . .]

• Glenmark’s generic equivalent of FloVent HFA fluticasone propionate MDI gets final approval from FDA

  According to Glenmark, the FDA has approved the company’s ANDA for a generic equivalent of GSK’s FloVent HFA fluticasone propionate MDI with competitive generic therapy (GGT) designation. FloVent HFA was initially approved in 2004, and… [Read more . . .]

• Rein Therapeutics restarts Phase 2 trial of LTI-03 inhaled dry powder synthetic peptide in patients with IPF

• AtaiBeckley announces plans for Phase 3 development of BPL-003 intranasal mebufotenin

• Esperion to acquire Corstasis Therapeutics and its Enbumyst bumetanide nasal spray

• Cullgen calls off merger with Pulmatrix

• SpliSense’s SPL84 inhaled antisense oligonucleotide for CF gets early PRIME designation from the EMA

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